D 75N95021Q00075_RFQ.pdf

COMBINED SYNOPSIS / SOLICITATION

75N95021Q00075

TITLE: In-vivo Efficacy Study of a Niclosamide Prodrug in a Golden Syrian Hamster Model of SARS-CoV-2 (COVID-19)

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95021Q00075 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures and FAR Part 12 - Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, effective February 16, 2021.

(iv) The associated NAICS code is 325414 and the Small Business size standard is 1,250 employees. This requirement is set aside exclusively for Small Business.

DESCRIPTION

(v) The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), with a mission to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

Niclosamide is an old anthelminthic drug. Its potential as an anti-cancer and anti-viral agent has been demonstrated in numerous recent publications and clinical trials aiming to utilize its potential beyond its historic use of treating tapeworm infections in the gut. These studies have continually faced challenges in terms of oral absorption due to niclosamide’s poor solubility and permeability.

NCATS has discovered niclosamide analogs with better solubility, permeability and microsomal stability, indicative of better in vivo exposures, but with similar potency in their ability to rescue the cytopathic effect of SARS-CoV-2 infection in cell-based studies.

NCATS also invested efforts in discovering niclosamide prodrugs that have better solubility and permeability and are effectively metabolized to the active drug. One of these promising prodrugs will now be tested in an animal model of SARS-CoV-2 infection.

The objective of this acquisition is to test NCATS’ prodrug in the Golden Syrian Hamster model, which has been identified as the species of choice for live virus SARS-CoV-2 efficacy studies.

See the attached Statement of Work for complete requirement details.

(vi) The Government anticipates a period of performance of four (4) weeks from receipt of test article compounds from NCATS or finalization of the study plan, whichever is later, but will be based on the schedule and timeline of the awardee. NCATS anticipates, but does not guarantee, sending the test article compounds within two (2) weeks after the date of award.

This requirement supports the development of therapeutics to combat COVID-19.

Timeliness is a critical factor in meeting the Government’s needs and the contractor must be able to begin work as quickly as possible after the date of award. Responses should indicate how much lead time is needed for the vendor to begin the efficacy study.

SPECIAL CONTRACT REQUIREMENTS

(vii) Contractor Requirements. The services under this contract involves live vertebrate animals. Respondents must have:

1. An active OLAW Animal Welfare Assurance

2. AAALAC accreditation

3. Institutional Animal Care and Use Committee (IACUC) project approval for this work. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

(viii) Animal Welfare. All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at:

http://grants1.nih.gov/grants/olaw/references/phspol.htm. In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor’s quotation.

(ix) Vertebrate Animals Section (VAS). It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals.

The VAS should be no more than two (2) pages and must address the following criteria:

1. Description of Procedures. Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the Statement of Work.

Identify the species, strains, ages, sex and total number of animals by species to be used in http://grants1.nih.gov/grants/olaw/references/phspol.htm the proposed work.

2. Justifications. Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g., computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress. Describe the interventions including analgesia, anesthesia, sedation, palliative care and humane endpoints to minimize discomfort, distress, pain and injury.

4. Euthanasia. State whether the method of euthanasia is consistent with the recommendations of the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals. If not, describe the method and provide a scientific justification.

For more discussion regarding the VAS, see NIH Guide Notice NOT-OD-16-006 at:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-006.html.

The VAS Worksheet is provided as an attachment to this solicitation to assist in the preparation of the VAS.

EVALUATION AND AWARD

(x) The anticipated award date is February 26, 2021.

(xi) The Government plans to award a fixed-price purchase order resulting from this solicitation.

The resulting award will be made to the responsible respondent whose quotation will be most advantageous to the Government, price and other factors considered. The Government will use comparative evaluations to determine which quotation is most advantageous, in consideration of the following evaluation criteria:

1. Meeting the contractor requirements listed in Paragraph (vii)

2. Technical Capability, which includes:

a) In-house capability to conduct live virus studies under BSL-3 conditions

b) Acceptability of the Vertebrate Animal Section (VAS)

c) How much lead time is needed for the vendor to begin the efficacy study

3. Past Performance, which includes:

a) Demonstrated experience running the Golden Syrian Hamster model of SARS-CoV-2 infection

b) Demonstrated experience generating preclinical data in SARS-CoV-2 models to support translation of therapeutic candidates into clinical evaluation

4. Price

SUBMISSION INSTRUCTIONS

(xii) All responses to this RFQ must be received by 9:00m Eastern Time on February 25, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to Kimberly Espinosa at kimberly.espinosa@nih.gov.

(xiii) This is an RFQ. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Any representations and/or certifications attached to this RFQ must be completed by the quoter.

(xiv) Responses to this RFQ must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses may exceed capability or performance characteristics of the solicitation's requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation's requirements if it provides a benefit to the Government.

(xv) Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer

Identification Number (TIN), the certification of business size, the OLAW Animal Welfare Assurance number, AAALAC accreditation, a Vertebrate Animal Section (VAS), Institutional Animal Care and Use Committee (IACUC) project approval, the completed representation in FAR Provisions 52.204-24 and 52.204-26 (attached), and a quotation that includes:

1. The total price (inclusive of all costs, fees, shipping, etc.),

2. Individual prices for each listed line item,

3. Prompt payment discount terms,

4. Product or catalog number(s),

5. Product/service description, and

6. Any other information or factors that may be considered in the award decision. Such factors may include: special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

(xvi) For information about this RFQ, contact Kimberly Espinosa, Contracting Officer, at 301-

827-3546 or kimberly.espinosa@nih.gov.

(xvii) All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

mailto:kimberly.espinosa@nih.gov

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xviii) The provision at HHSAR 352.270-5a, Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (December 18, 2015). The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy) establishes a number of requirements for research activities involving animals. Before awarding a contract to an offeror, the organization shall file, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), a written Animal Welfare Assurance (Assurance) which commits the organization to comply with the provisions of the PHS Policy, the Animal Welfare Act, and the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC). In accordance with the PHS Policy, offerors must establish an Institutional Animal Care and Use Committee (IACUC), qualified through the experience and expertise of its members, to oversee the institution’s animal program, facilities, and procedures. Offerors must provide verification of IACUC approval prior to receiving an award involving live vertebrate animals. No award involving the use of animals shall be made unless OLAW approves the Assurance and verification of IACUC approval for the proposed animal activities has been provided to the Contracting Officer. Prior to award, the Contracting Officer will notify Contractor(s) selected for projects involving live vertebrate animals of the Assurance and verification of IACUC approval requirement. The Contracting Officer will request that OLAW negotiate an acceptable Assurance with those Contractor(s) and request verification of IACUC approval. For further information, contact OLAW at NIH, 6705 Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301-496-7163).

(End of provision)

(xix) The clause at HHSAR 352.270-5b, Care of Live Vertebrate Animals (December 18, 2015).

(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; website:

http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause)

(xx) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb

1998). This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:

1. The provision at FAR 52.204-7, System for Award Management (Oct 2018)

2. The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting

(Aug 2020)

3. The provision at 52.212-3, Offeror Representations and Certifications—Commercial

Items (Nov 2020)

(xxi) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

1. The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

2. The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance

(Aug 2020)

3. The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Oct

2018)

4. The clause at FAR 52.227-14, Rights in Data-General (May 2014). Under 52.227-

14(c)(1), the contractor must obtain approval from the contracting officer to assert copyright in any data first produced in performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works.

Under 52.227-14(d)(2), the contractor must obtain approval from the contracting officer to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the contractor in the performance of this contract.

5. The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015)

6. The clause at HHSAR 352.223-70, Safety and Health (December 18, 2015)

7. The clause at HHSAR 352.224-71 Confidential Information (December 18, 2015)

(c)(2)(i) The publication or dissemination of the following types of information are restricted under this contract: information about niclosamide prodrug.

(c)(2)(ii) The reason for restricting the types of information identified in subparagraph (i) is: This compound is the proprietary intellectual property of the Government.

(xxii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

ATTACHMENTS

(xxiii) The following are attached in full text:

1. Statement of Work

2. VAS Worksheet

3. The provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020)

4. The provision at FAR 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020)

5. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement

Statutes or Executive Orders–Commercial Items (Jan 2021)

6. The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Jun 2020)

(Tailored)

7. NIH Invoicing Instructions (Feb 2021)